NCT04956133

Brief Summary

Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Aug 2022Jun 2028

First Submitted

Initial submission to the registry

June 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 3, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 7, 2025

Status Verified

February 1, 2025

Enrollment Period

5.3 years

First QC Date

June 11, 2021

Last Update Submit

March 4, 2025

Conditions

Pediatric CancerPediatric Hematology

Keywords

Childhood cancerAdolescent cancerIn-patientOut-patientOncologyHematology

Outcome Measures

Primary Outcomes (1)

  • Reach

    The number of people who participate, and reasons why or why not.

    Through study completion, an average of 6 years.

Secondary Outcomes (19)

  • Attendance

    Through study completion, an average of 6 years.

  • Adherence

    Through study completion, an average of 6 years.

  • Self-Reported Physical Activity Behaviour

    Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  • Directly Assessed Physical Activity Behaviour

    Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  • Functional Mobility

    Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  • +14 more secondary outcomes

Study Arms (1)

Physical activity

EXPERIMENTAL

Participants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks.

Behavioral: Physical Activity

Interventions

Physical ActivityBEHAVIORAL

Participants will receive the IMPACT program, which includes a combination of aerobic, resistance, balance, and flexibility exercises conducted 1:1 and delivered online by a physical activity specialist via Zoom. The IMPACT program follows basic physical activity progression principles (i.e., principles of frequency, intensity, time, type, overload and progression). Tailoring will be used to promote fitness and wellness benefits, while ensuring safety. In addition, prominent behaviour change techniques will be provided by physical activity specialists within each 1:1 session. Discussions and worksheets will be provided, depending on participants needs.

Physical activity

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise)
  • Diagnosed with any oncological and/or hematological diagnosis
  • Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment \<3 months

You may not qualify if:

  • Completed all treatment for their oncological or hematological diagnosis \>3 months
  • Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist
  • Parent and/or patient cannot understand verbal English
  • Parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

RECRUITING

Related Publications (16)

  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PMID: 4053261BACKGROUND

  • Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.

    PMID: 24229362BACKGROUND

  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND

  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PMID: 7624188BACKGROUND

  • Deforche B, Lefevre J, De Bourdeaudhuij I, Hills AP, Duquet W, Bouckaert J. Physical fitness and physical activity in obese and nonobese Flemish youth. Obes Res. 2003 Mar;11(3):434-41. doi: 10.1038/oby.2003.59.

    PMID: 12634442BACKGROUND

  • Canadian Society of Exercise Physiology. (2019). The CSEP physical activity training for health resource manual, 2nd edition.

    BACKGROUND

  • McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.

    PMID: 31519676BACKGROUND

  • Muir SW, Corea CL, Beaupre L. Evaluating change in clinical status: reliability and measures of agreement for the assessment of glenohumeral range of motion. N Am J Sports Phys Ther. 2010 Sep;5(3):98-110.

    PMID: 21589666BACKGROUND

  • Lemmink KA, Kemper HC, de Greef MH, Rispens P, Stevens M. The validity of the sit-and-reach test and the modified sit-and-reach test in middle-aged to older men and women. Res Q Exerc Sport. 2003 Sep;74(3):331-6. doi: 10.1080/02701367.2003.10609099. No abstract available.

    PMID: 14510299BACKGROUND

  • Kolber MJ, Hanney WJ. The reliability and concurrent validity of shoulder mobility measurements using a digital inclinometer and goniometer: a technical report. Int J Sports Phys Ther. 2012 Jun;7(3):306-13.

    PMID: 22666645BACKGROUND

  • Jankowski M, Niedzielska A, Brzezinski M, Drabik J. Cardiorespiratory fitness in children: a simple screening test for population studies. Pediatr Cardiol. 2015 Jan;36(1):27-32. doi: 10.1007/s00246-014-0960-0. Epub 2014 Jul 29.

    PMID: 25070386BACKGROUND

  • Haas F, Sweeney G, Pierre A, Plusch T, Whiteson J. Validation of a 2 minute step test for assessing functional improvement. Open J Therap Rehab. 2017;5(02):71.

    BACKGROUND

  • Varni JW, Limbers CA. The pediatric quality of life inventory: measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatr Clin North Am. 2009 Aug;56(4):843-63. doi: 10.1016/j.pcl.2009.05.016.

    PMID: 19660631BACKGROUND

  • Hyslop S, Dupuis LL, Baggott C, Dix D, Gibson P, Kuczynski S, Johnston DL, Orsey A, Portwine C, Price V, Spiegler B, Tomlinson D, Vanan M, Tomlinson GA, Sung L. Validation of the Proxy Version of Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Pain Symptom Manage. 2018 Jul;56(1):107-112. doi: 10.1016/j.jpainsymman.2018.03.025. Epub 2018 Apr 6.

    PMID: 29630923BACKGROUND

  • Gioia GA, Issquith PK, Guy SC, Kenworthy L. Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2). 2015. Lutz, FL: PAR Inc.

    BACKGROUND

  • McLaughlin E, Culos-Reed SN, Chamorro-Vina C, Wilson B, Fisher S, Guilcher GM, Penney B, Penney M, Wich L, Wich J, Wurz A. IMplementation of Physical Activity for Children and adolescents on Treatment (IMPACT) for Cancer Diagnoses in Alberta: Protocol for a Single-Arm, Mixed-Methods, Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Dec 17;14:e59302. doi: 10.2196/59302.

    PMID: 41406465DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

S. Nicole Culos-Reed, PhD

CONTACT

403-220-7540nculosre@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

July 9, 2021

Study Start

August 3, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

March 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)